Precision Fluidics Division Parker Hannifin Corp.
Hatfield, PA, US
PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP. appears in FDA device records in Hatfield, PA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Precision Fluidics Division Parker Hannifin Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Porter Instrument Co., Inc.510(k), recall
510(k) clearance history
FDA records hold 6 510(k) clearances for Precision Fluidics Division Parker Hannifin Corp. between 1980 and 2006. The busiest year on record is 1980, with 1. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1990 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1998 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K062155 | DIGITAL MXR-D FLOWMETER | BSZ | Substantially Equivalent | |
| K981754 | AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 | CBN | Substantially Equivalent | |
| K924596 | SES-2012 AUTOMATIC STEAM STERILIZER | FLE | Substantially Equivalent | |
| K923781 | MXR-2000 FLOWMETER | CAX | Substantially Equivalent | |
| K895638 | STEAM STERILIZER (AUTOCLAVE), DENTAL | FLE | Substantially Equivalent | |
| K802067 | CLEAN-AIR POLLUTION REDUCTION SYSTEM | CBN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2518157 | 2518157 | PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP. | 245 Township Line Rd, HATFIELD, PA 19440 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CBNApparatus, Gas-Scavenging
- BTCBag, Reservoir
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BXYFlowmeter, Calibration, Gas
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated
- BSZGas-Machine, Anesthesia
- BXHGauge, Gas Pressure, Cylinder/Pipeline
- BSJMask, Gas, Anesthetic
- KHAMask, Scavenging
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- BYPMouthpiece, Breathing
- FOXStand, Infusion
- FLESterilizer, Steam
- BYXTubing, Pressure And Accessories
- BTMVentilator, Emergency, Manual (Resuscitator)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0228-2009 | Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a connection function for complete delivery of mixed gases to the breathing circuit portion of the gas scavenging apparatus. The Bag Tee assembly features a non-breathing valve and an Emergency Air Intake located on the bag tee which comply with the American Dental Association guidelines. | inverted check value on the bag tee assembly which can cause leaking of mixed N2O/O2 gas | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain